MR41928: Patient Experience and Preference (PEP) Study in nAMD and DME
Research type
Research Study
Full title
Patient Experience and Preference (PEP) Study in nAMD and DME
IRAS ID
288899
Contact name
Mirela Mirt Dabic
Contact email
Sponsor organisation
F-Hoffman La-Roche Ltd
Duration of Study in the UK
0 years, 3 months, 20 days
Research summary
Age-related macular degeneration (AMD) is a neurodegenerative disease of the central retina that causes irreversible destruction of the macula, which leads to loss of the sharp, fine-detail, “straight ahead” vision that is required for activities such as driving, reading, seeing in color and recognizing faces. Neovascular AMD (nAMD) accounts for most cases of AMD‐related severe vision loss, and owing to the degenerative nature of the disease, the incidence of nAMD is projected to increase with the aging of the population. Diabetic macular edema (DME) is a common microvascular complication in patients with diabetes and may have a sudden and debilitating impact on visual acuity (VA) that can eventually lead to blindness. Anti-vascular endothelial growth factor (anti-VEGF) therapies (e.g., ranibizumab, aflibercept) have been successful in improving and preserving vision and quality of life for patients with nAMD or DME. However, evidence suggests that real-world outcomes for patients with nAMD or DME lag behind those documented in clinical trials. Qualitative research (e.g., literature review; Patients with nAMD or DME, caregivers and Physicians qualitative concept elicitation telephone interviews) were previously conducted by Roche in order to inform the development of cross-sectional surveys for patients and their caregivers (4 surveys) to be administered in this proposed study. The current proposal is a multi-national, cross-sectional, non-interventional study (NIS) and the targeted countries are: United States; Canada, France, Germany, Italy, Spain and the United Kingdom. The NIS involves administering a one-off quantitative survey and discrete choice experiment (DCE) among patients (>18 years) globally with nAMD (n=900) and DME (n=900) and their caregivers (n=360-720). Medical chart extraction will be conducted to obtain clinical information for patients participating in the survey. Aspects of the patient experience assessed by the survey will be associated with treatment patterns and clinical outcomes extracted from the medical records.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0013
Date of REC Opinion
7 Jan 2021
REC opinion
Favourable Opinion